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Glucocorticosteroid Treatment in Acute Unilateral Vestibulopathy (Vestibular Neuronitis)

Primary Purpose

Acute Peripheral Vestibulopathy

Status

Completed

Phase

Phase 4

Locations

Study Type

Interventional

Intervention

Prednisone

About this trial

This is an interventional treatment trial for Acute Peripheral Vestibulopathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Medical History :

severe and prolonged rotatory vertigo;
acute onset, subacute, within 3 days;
nausea ;
imbalance.

Physical examination :

spontaneous nystagmus beating towards the healthy ear (fast phase);
no evidence of central vestibular lesion;
Head impulse test abnormal, at least for the lateral semicircular canal (in some cases, the sign is only detectable for the 2 vertical semicircular canals with specific equipment, mostly not available in current practice);
areflexia or hyporeflexia (asymetry > 70% calculated according to the classical Jongkees formula [slow phase velocity of the nystagmus in response to caloric stimulation at (right at 30°C + right at 44°C) - ( left at 30°C + left at 44°C ) / (right 30°C + left 30°C + right 44°C + left at 44°C) x 100], in the caloric test (10 cc in 20 s, at 30 and 44° C)

Exclusion Criteria:

history of vestibular disorders other than benign paroxysmal positionning vertigo (BPPV);
symptoms lasting more than 3 days;
cochlear symptoms (deafness before, during or after vertigo);
central oculomotor dysfunction;
central vestibular dysfunction;
signs of brain dysfunction (e.g. epilepsy);
MRI (if done) abnormal central vestibular pathways;
psychiatric disease (history of psychiatric disease);
glaucoma ;
acute infection (herpes simplex, herpes zoster, corneal herpes, chicken pox, tuberculosis);
patients already on corticosteroids;
severe diabetes (fasting blood glucose > 7 mmol/l);
Severe hypertension (systolic >180; diastolic > 110);
contraindications to glucocorticoids (peptic ulceration, osteoporosis confirmed by bone density tests or pathological fractures);
allergy to glucocorticoids or mannitol
malignant disease;
cardiac disease (recent myocardial infarction, heart failure);
liver dysfunction (cirrhosis)
renal insufficiency;
Pregnancy or breastfeeding.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Prednisone

Placebo

Arm Description

Prednisone, 60mg/d, for 10 days

Outcomes

Primary Outcome Measures

Bithermal calorics asymetry

Secondary Outcome Measures

Dizziness Hanidcap Inventory (Questionnaire)

min: 0 / max:100, higher score is worse

Full Information

NCT ID

NCT05024448

First Posted

July 28, 2021

Last Updated

August 26, 2021

Sponsor

University Hospital, Geneva

1. Study Identification

Unique Protocol Identification Number

NCT05024448

Brief Title

Glucocorticosteroid Treatment in Acute Unilateral Vestibulopathy (Vestibular Neuronitis)

Official Title

Glucocorticosteroid Treatment in Acute Unilateral Vestibulopathy, a Multicentric, Randomized, Double-blind, Placebo-controlled Study

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

August 27, 2013 (Actual)

Primary Completion Date

June 9, 2021 (Actual)

Study Completion Date

June 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University Hospital, Geneva

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The vestibular system is a part of the inner ear and functions as a motion sensor. It provides the central nervous system with information about changes of the head position. This information is essential for the proper functioning of the balance system. In particular, it ensures effective postural control and gaze stabilization. Abrupt vestibular deficit is defined as a sudden loss of the vestibular function. In the acute phase the patient presents mainly with intense rotatory vertigo and instability, most often accompanied by nausea. The symptoms are exacerbated by head movements. The diagnosis is made by observation of a spontaneous nystagmus, measurement of a pathological head impulse test and an asymmetric response to caloric tests, in the absence of other neurological symptoms. Although the etiology is unknown, it could be of viral or vascular origin. Symptoms usually regress within a few days or weeks. Vestibular function recovers in about half of the cases, in the other half a central compensation process is set up. The benefit of a 3-week course of corticosteroids has been demonstrated in one study. The dosage has been debated. The aim of this study is to demonstrate the benefit of a 10-day course of oral corticosteroids. The primary objective is to demonstrate a significant reduction in the rate of asymmetry of caloric response and the secondary objective is to demonstrate a significant reduction in the impact of symptoms assessed with the Dizziness Handicap Inventory (DHI) score at 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Peripheral Vestibulopathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

96 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prednisone

Arm Type

Active Comparator

Arm Description

Prednisone, 60mg/d, for 10 days

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Prednisone

Intervention Description

oral administration, 60mg/d for 10d

Primary Outcome Measure Information:

Title

Bithermal calorics asymetry

Time Frame

Day 1

Title

Bithermal calorics asymetry

Time Frame

Day 21

Title

Bithermal calorics asymetry

Time Frame

Day 365

Secondary Outcome Measure Information:

Title

Dizziness Hanidcap Inventory (Questionnaire)

Description

min: 0 / max:100, higher score is worse

Time Frame

Day 1, Day 21, Day 365

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Medical History : severe and prolonged rotatory vertigo; acute onset, subacute, within 3 days; nausea ; imbalance. Physical examination : spontaneous nystagmus beating towards the healthy ear (fast phase); no evidence of central vestibular lesion; Head impulse test abnormal, at least for the lateral semicircular canal (in some cases, the sign is only detectable for the 2 vertical semicircular canals with specific equipment, mostly not available in current practice); areflexia or hyporeflexia (asymetry > 70% calculated according to the classical Jongkees formula [slow phase velocity of the nystagmus in response to caloric stimulation at (right at 30°C + right at 44°C) - ( left at 30°C + left at 44°C ) / (right 30°C + left 30°C + right 44°C + left at 44°C) x 100], in the caloric test (10 cc in 20 s, at 30 and 44° C) Exclusion Criteria: history of vestibular disorders other than benign paroxysmal positionning vertigo (BPPV); symptoms lasting more than 3 days; cochlear symptoms (deafness before, during or after vertigo); central oculomotor dysfunction; central vestibular dysfunction; signs of brain dysfunction (e.g. epilepsy); MRI (if done) abnormal central vestibular pathways; psychiatric disease (history of psychiatric disease); glaucoma ; acute infection (herpes simplex, herpes zoster, corneal herpes, chicken pox, tuberculosis); patients already on corticosteroids; severe diabetes (fasting blood glucose > 7 mmol/l); Severe hypertension (systolic >180; diastolic > 110); contraindications to glucocorticoids (peptic ulceration, osteoporosis confirmed by bone density tests or pathological fractures); allergy to glucocorticoids or mannitol malignant disease; cardiac disease (recent myocardial infarction, heart failure); liver dysfunction (cirrhosis) renal insufficiency; Pregnancy or breastfeeding.

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Glucocorticosteroid Treatment in Acute Unilateral Vestibulopathy (Vestibular Neuronitis)

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